Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0983-2018 — Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be

U.S. FDA — Device Enforcement · United States · 2017-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0983-2018
Date of alert: 2017-11-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alden Optical
Product category: device
Product type: Devices

Reported risk: Contact lenses lack sterility assurance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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